This part of ISO 10555 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
This part of ISO 10555 does not specify requirements, performance, and user safety issues related to non-coring needles.
NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as intra-peritoneal, intra-thecal, intra-pleural, and epidural access.
Cross References:ISO 10555-3:2013
EN ISO 10555-1:2013
ISO 10555-1:2013
EN ISO 10555-3:2013
ISO 5832-1:2016
ASTM F2182 - 11a
ASTM F2213 - 06
ISO 594-1:1986
ISO 9584:1993 (R08)
ISO 48:2010
ISO 10993-1:2009
ISO 11135-1:2007
ISO 5832-2:1999
ISO 7864:2016
ISO 17665-1:2006
ASTM F2119 - 07
ISO 6474-1:2010
ASTM F2052 - 06e1
Incorporates the following:Amendment, November 2019
| File Size : | 1
file
, 2 MB |
| ISBN(s) : | 9780539038118 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30390863, 30390863, 30390863 |
| Published : | 11/05/2019 |